IMA probe finds 'procedural anomalies'

By Our Staff Reporter

THIRUVANANTHAPURAM, SEPT. 14. A commission of inquiry instituted by the State unit of the Indian Medical Association to probe the controversial clinical trial conducted on a group of patients at the Regional Cancer Centre (RCC), has reported ``procedural anomalies'' in the implementation of the foreign-funded venture even while exonerating the premier institution of any mala fide intent in undertaking the research venture.

The RCC's clinical trial launched with funding from the Baltimore-based Johns Hopkins University to test the medical applicability of Nordihydroguaiarectic acid (NDGA) derivatives, had generated controversy and a raging debate on ethics and morality after a senior clinical radiobiologist at the institution petitioned the Human Rights Commission on alleged violation of patient rights during the trial.

The IMA inquiry commission's finding, which were released to the media today, states that ``institutional arrangements have not been strictly adhered to'' and that ``the trial was started much before the official approval'' of the Drugs Controller General of India.

``There is a disparity between the dates of starting the trial and the formal sanction of the competent authority,'' the report observes. It adds that the RCC had also failed to strictly comply with provisions spelt out in Schedule Y of the Drugs and Cosmetics Act (1940), which requires prior permission of the DGCI before commencement of a trial of this nature. Further, the drug substance for the trial was ``probably brought much before the import licence was issued,'' the report states.

At the same time, the commission states that there was no evidence that the M4N and G4N chemicals were banned substances.

The commission opines that although the trial has followed the standard consent form and patient information brochures as approved by the institutional ethics committee, it is doubtful whether all patients clearly understood that they were participating in a human experiment. ``To that extent, there has been a procedural anomaly. At least in one case we understood the patient did not understand Malayalam.''

In another context (determining whether any patient had been harmed by participation in the trial), the commission states that interviews with eight of the 25 patients, only whose addresses were made available to the IMA, indicated that none of them had been in any way been harmed by participating in the experiment. ``As per available scientific literature, this substance is not soluble in water and lipids. The chances of dissemination in the system after getting injected into the lesion are very remote''.

However, the report dismisses any prospect of mala fide intent behind the RCC's taking up the foreign-funded trial. It adds that this was the first trial of its kind taken up by the institution which had been offering clinical and research services to the State in the area of cancer care.

In all other aspects, ranging from ensuring principles of essentiality, privacy and confidentiality of subjects, maintaining of accountability and transparency, maximisation of public interest and distributive justice, and being non- exploitative, the study had complied with ICMR guidelines (2000), the report says.

Towards improving the law on clinical trial of drugs and related matters, the IMA has suggested adequate research grants from the State and Central Governments, financial reward for participant subjects, reporting of ethical violations only to the MCI or ICMR, and promulgation of elaborate guidelines and stringent laws to govern drug trials on humans, including sharing of intellectual property rights in international collaboration studies. It also appealed for applying these laws and guidelines uniformly for all systems of medicine, such as Ayurveda and Homoeopathy.

The main terms of reference of the inquiry commission were whether the above trial abided by the guidelines of the Indian Council of Medical Research, whether the experiment had any mala fide intentions, whether the experiment violated existing laws, whether any patients on whom the experiment had been conducted been harmed in any way, whether the existing provisions for a substance before being released as a drug for human use was satisfactory and whether the same are applicable to all systems of medicine.

The commission of inquiry comprised Dr. R. V. Asokan, Dr. V. C. Velayudhan Pillai, Dr. A. Marthanda Pillai, Dr. Kasi Visweswaran and Dr. T. Suresh Kumar.

The inputs for the inquiry were collected by procurement of documents from the researchers, physicians, Internet, media reports and depositions by the public.

The IMA team also interacted with, among others, Dr. M. Krishnan Nair, RCC Director, Dr. Manoj Pandey, the co- investigator for the trial, Dr. V. N. Bhattathiri, Dr. V. P. Gangadharan and Dr. Venkatakrishnan, State Drugs Controller.

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